• How To Ace Your Next CDMO Capabilities Audit
    How To Ace Your Next CDMO Capabilities Audit

    A capabilities audit is an integral part of a sponsor's due diligence in vendor procurement. It is often the sponsor’s first exposure to a CDMO’s operations, and the primary objectives are to evaluate the facility, equipment, quality systems, and the expertise of each functional team in relation to the specific needs of the project.

  • Developing Optimal Pharmaceutical Quality Control Strategies
    Developing Optimal Pharmaceutical Quality Control Strategies

    How can the industry improve the quality of its products? The first tactic could be to increase the frequency of vendor inspections, using internal quality control programs to inspect suppliers to assure compliance with the necessary supply agreements and adherence to appropriate manufacturing practices, including GMPs.

  • Are Biopharma's Strong Pipeline Innovations Reaching Patients?
    Are Biopharma's Strong Pipeline Innovations Reaching Patients?

    The number of new chemical entities gaining FDA approval more than doubled from 2017 to 2018. Global R&D spending increased 3.5%. The pipeline is strong, but how many innovations are actually reaching patients?

More From Guest Contributors


Enhancing Bioavailability When Developing Oral Solid Formulations Enhancing Bioavailability When Developing Oral Solid Formulations

Methods for improving bioavailability are constantly evolving. Selecting the right approach is key to achieving a good formulation that reduces the frequency of dosing and improves patient compliance, as well as results in a low production cost.

Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective

There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

Bioburden: Address Microbial Contamination In Downstream Bioprocessing

A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.

Benefits And Challenges Of Driving Modernization In Vaccine Development

Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.

Unlocking The Potential For Efficiency In Downstream Bioprocesses

In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.

6 Regulatory Changes Affecting Bioprocessing In China

This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

More From OP White Papers - random


Environmental Life Cycle Assessment of Single-Use Technologies

Single-use technologies offer an attractive option for biopharmaceutical manufacturing, but their environmental impact needs be considered.

Process For Scale-Up Of Adherent Vero Cells From Static Cell Factories To Influenza Production

In cell culture-based vaccine production, scale-up of adherent cells is challenging. This study shows a process for scaling up adherent Vero cells from static cell factories to influenza production at 50 L scale using WAVE Bioreactor™ systems and ReadyToProcess single-use equipment.

Controlling Complexity (Not Cost) Of Advanced Therapy Supply Chains

Due to the short shelf life and clinical criticality of advanced therapies, their supply chains are often highly complex.  Once efficacy and safety is demonstrated, the focus of advanced therapy developers moves to controlling cost.  However, the biggest cost within the supply chain is caused by its complexity.  In this article, we will share why the advanced therapy supply chain is so complex and how this complexity correlates to cost.

Are You Ready For The Future of Biomanufacturing?

As novel medicines become a larger part of the industry's portfolio, it is critical you secure a supply chain and manufacturing processes that produce drugs in a reliable, cost-effective way. 

More Pharma Outsourcing App Notes & Case Studies


Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

Louis Garguilo Articles



More Industry Insights


DIA 2019 Global Annual Meeting June 23 - 27, 2019
San Diego, CA
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response June 26 - 26, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
22nd International Conference and Exhibition on P July 4 - 6, 2019
Valencia, Spain
Executing Proper Event Investigations: Critical Steps In Ensuring Compliant Corrective Actions July 10 - 10, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $199 - Includes Bonus Handouts!
More Industry Events